510(k) K915757
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1992
- Date Received
- December 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device Class
- Class II
- Regulation Number
- 870.5550
- Review Panel
- CV
- Submission Type